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随机、双盲、安慰剂对照试验:N-乙酰半胱氨酸增强治疗抵抗性强迫症。

Randomized, Double-Blind, Placebo-Controlled Trial of N-Acetylcysteine Augmentation for Treatment-Resistant Obsessive-Compulsive Disorder.

机构信息

Department & Institute of Psychiatry, University of São Paulo Medical School, Rua Dr, Ovídio Pires de Campos, 485, 3° andar, CEAPESQ, sala 7, CEP 05403-010, São Paulo-SP, Brazil.

Department & Institute of Psychiatry, University of São Paulo Medical School, São Paulo, Brazil.

出版信息

J Clin Psychiatry. 2017 Jul;78(7):e766-e773. doi: 10.4088/JCP.16m11101.

DOI:10.4088/JCP.16m11101
PMID:28617566
Abstract

OBJECTIVE

To evaluate the efficacy of serotonin reuptake inhibitor (SRI) augmentation with N-acetylcysteine (NAC), a glutamate modulator and antioxidant medication, for treatment-resistant obsessive-compulsive disorder (OCD).

METHODS

We conducted a randomized, double-blind, placebo-controlled, 16-week trial of NAC (3,000 mg daily) in adults (aged 18-65 years) with treatment-resistant OCD, established according to DSM-IV criteria. Forty subjects were recruited at an OCD-specialized outpatient clinic at a tertiary hospital (May 2012-October 2014). The primary outcome measure was the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) scores. To evaluate the variables group, time, and interaction effects for Y-BOCS scores at all time points, we used nonparametric analysis of variance with repeated measures. Secondary outcomes were the severity scores for anxiety, depression, specific OCD symptom dimensions, and insight.

RESULTS

Both groups showed a significant reduction of baseline Y-BOCS scores at week 16: the NAC group had a reduction of 4.3 points (25.6 to 21.3), compared with 3.0 points (24.8 to 21.8) for the placebo group. However, there were no significant differences between groups (P = .92). Adding NAC was superior to placebo in reducing anxiety symptoms (P = .02), but not depression severity or specific OCD symptom dimensions. In general, NAC was well tolerated, despite abdominal pain being more frequently reported in the NAC group (n [%]: NAC = 9 [60.0], placebo = 2 [13.3]; P < .01).

CONCLUSIONS

Our trial did not demonstrate a significant benefit of NAC in reducing OCD severity in treatment-resistant OCD adults. Secondary analysis suggested that NAC might have some benefit in reducing anxiety symptoms in treatment-resistant OCD patients.

TRIAL REGISTRATION

ClinicalTrials.gov identifier: NCT01555970.

摘要

目的

评估 5-羟色胺再摄取抑制剂(SSRIs)与 N-乙酰半胱氨酸(NAC)联合治疗,谷氨酸调节剂和抗氧化药物,治疗难治性强迫症(OCD)的疗效。

方法

我们进行了一项随机、双盲、安慰剂对照、16 周的 NAC(每天 3000 毫克)治疗难治性 OCD 成人(18-65 岁)的试验,根据 DSM-IV 标准建立。40 名患者在一家三级医院的 OCD 专科门诊招募(2012 年 5 月至 2014 年 10 月)。主要观察指标是耶鲁-布朗强迫量表(Y-BOCS)评分。为了评估所有时间点 Y-BOCS 评分的变量组、时间和交互效应,我们使用非参数重复测量方差分析。次要结果是焦虑、抑郁、特定 OCD 症状维度和洞察力的严重程度评分。

结果

两组在第 16 周时均显示出 Y-BOCS 评分的显著降低:NAC 组降低了 4.3 分(25.6 至 21.3),而安慰剂组降低了 3.0 分(24.8 至 21.8)。然而,两组之间没有显著差异(P =.92)。与安慰剂相比,添加 NAC 可更好地降低焦虑症状(P =.02),但不能降低抑郁严重程度或特定 OCD 症状维度。总的来说,NAC 耐受性良好,尽管 NAC 组更常报告腹痛(NAC = 9 [60.0],安慰剂 = 2 [13.3];P <.01)。

结论

我们的试验并未表明 NAC 可显著降低治疗抵抗性 OCD 成人的 OCD 严重程度。二次分析表明,NAC 可能对治疗抵抗性 OCD 患者的焦虑症状有一定的缓解作用。

试验注册

ClinicalTrials.gov 标识符:NCT01555970。

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